title: Can simvastatin improve erectile function and health-related quality of life in men aged >40 years with erectile dysfunction? Rationale and design of the Erectile Dysfunction and Statins (EDS) Trial [ISRCTN66772971](1).
abstract: What's known on the subject? and What will the study add? Erectile dysfunction is often associated with endothelial dysfunction. It is also recognized as a marker for underlying vascular disease. This study tests the hypothesis that statin therapy may improve erectile function and also reduce the risk of future cardiovascular events via a reduction in serum cholesterol and by improving endothelial function. The study will also determine whether the treatment improves quality of life related to sexual function.
  
  
  OBJECTIVE
  • To describe the rationale and design of the Erectile Dysfunction and Statins (EDS) Trial which aims to evaluate the effectiveness of simvastatin on erectile function and health-related quality of life in men aged ≥40 years with erectile dysfunction.
  
  
  METHODS
  • The study is a randomized, double-blind, placebo-controlled trial to test the hypotheses that statins improve endothelial function and reduce cholesterol and may improve erectile function in men with untreated erectile dysfunction (ED). • Study subjects are men ≥40 years who are not receiving lipid-lowering or anti-hypertensive medication and have no other cardiovascular disease (CVD) risk factors. • Eligible men with untreated ED are randomized to double-blind treatment with 40 mg simvastatin or placebo once daily for 6 months. • Data are collected at baseline, mid-trial and at the final follow-up visit at 30 weeks. • The main outcome is erectile function measured by the five-item version of the International Index of Erectile Function. Secondary outcomes include sexual-health-related quality of life and endothelial function.
  
  
  RESULTS
  • Ten general practices have been recruited in the east of England. • We have randomized 173 men for a power of 90% to assess the main outcome. • To date there have been no serious unexpected adverse events. • Study findings will be available in September 2011.
  
  
  CONCLUSIONS
  • If simvastatin improves erectile function it would provide an inexpensive treatment for ED suitable for most men, and reduce the risk of future CVD.
authors.affiliation: Centre for Research in Primary and Community Care, University of Hertfordshire, Hatfield, UK. d.trivedi@herts.ac.uk
authors.forename: Daksha
authors.initials: D
authors.lastname: Trivedi
authors.forename: Michael
authors.initials: M
authors.lastname: Kirby
authors.forename: Felicity
authors.initials: F
authors.lastname: Norman
authors.forename: Izabela
authors.initials: I
authors.lastname: Przybytniak
authors.forename: Shehzad
authors.initials: S
authors.lastname: Ali
authors.forename: David M
authors.initials: DM
authors.lastname: Wellsted
mesh_terms: D000328:Adult; D000368:Aged; D004311:Double-Blind Method; D004730:Endothelium, Vascular / Q000187:drug effects; D007172:Erectile Dysfunction / Q000188:drug therapy* / Q000523:psychology; D006801:Humans; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D011788:Quality of Life; D019821:Simvastatin / Q000627:therapeutic use*; D016896:Treatment Outcome
chemical_list: D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors; D019821:Simvastatin